Biometrics answers the questions posed by the studies on the basis of the study data using appropriate statistical methods.  

What we offer

Our experts will be glad to take over the following services for you:
  • Preparation of the statistical sections of the study protocol  
  • Support in the selection of clear study objectives and analysable endpoints, which are essential for a meaningful analysis  
  • Determination of the required study size in order to be able to clearly answer the research question (case number estimation, power analysis)  
  • Preparation of the statistical analysis plan (SAP)
  • Development of a randomisation process to allocate participants to treatment groups, especially for complex study designs. Randomisation and creation of contingency envelope
  • Biometric data analysis (according to ICH E9)  
  • Consultancy and advisory services  
  • Preparation of a final report, according to ICH E3, ISO 14155 or EMA/48663/2013, customised according to your specifications